alemtuzumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
humanized origin	4909	216503-57-0

Description:

Molecule	Description
Synonyms: campath alemtuzumab lemtrada	Alemtuzumab binds to CD52, an antigen present on the surface of B and T lymphocytes, a majority of monocytes, macrophages, NK cells, and a subpopulation of granulocytes. A proportion of bone marrow cells, including some CD34+ cells, express variable levels of CD52. The proposed mechanism of action is antibody-dependent cellular-mediated lysis following cell surface binding of alemtuzumab to the leukemic cells. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

campath
alemtuzumab
lemtrada

Alemtuzumab binds to CD52, an antigen present on the surface of B and T lymphocytes, a majority of monocytes, macrophages, NK cells, and a subpopulation of granulocytes. A proportion of bone marrow cells, including some CD34+ cells, express variable levels of CD52. The proposed mechanism of action is antibody-dependent cellular-mediated lysis following cell surface binding of alemtuzumab to the leukemic cells.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
0.13	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
May 7, 2001	FDA	GENZYME
Sept. 26, 2014	PMDA	SANOFI K.K.

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Lymphocyte count decreased	955.64	15.20	443	41115	29814	63417650
Immune thrombocytopenia	835.43	15.20	299	41259	10257	63437207
Urine abnormality	738.50	15.20	246	41312	6773	63440691
Urinary sediment present	484.00	15.20	136	41422	2067	63445397
Multiple sclerosis relapse	473.24	15.20	329	41229	48149	63399315
White blood cells urine positive	457.16	15.20	159	41399	4999	63442465
Urine leukocyte esterase positive	455.78	15.20	145	41413	3434	63444030
Red blood cells urine positive	441.21	15.20	137	41421	2989	63444475
Lymphocyte percentage decreased	388.64	15.20	123	41435	2862	63444602
Blood urine present	376.39	15.20	188	41370	14881	63432583

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Cytomegalovirus infection	640.19	16.44	314	20988	25821	34909808
Post transplant lymphoproliferative disorder	377.26	16.44	144	21158	6384	34929245
Immune thrombocytopenia	376.47	16.44	158	21144	8994	34926635
Adenovirus infection	250.97	16.44	101	21201	5156	34930473
Autoimmune haemolytic anaemia	234.21	16.44	92	21210	4404	34931225
Lymphopenia	229.92	16.44	136	21166	16199	34919430
Epstein-Barr virus infection	224.10	16.44	104	21198	7524	34928105
Progressive multifocal leukoencephalopathy	168.81	16.44	93	21209	9671	34925958
Graft versus host disease	164.61	16.44	94	21208	10475	34925154
Lymphocyte count decreased	160.26	16.44	123	21179	22499	34913130

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Lymphocyte count decreased	1015.91	13.52	555	58489	46734	79638610
Immune thrombocytopenia	928.47	13.52	385	58659	17420	79667924
Cytomegalovirus infection	920.12	13.52	502	58542	42142	79643202
Urine abnormality	783.50	13.52	276	58768	7943	79677401
Multiple sclerosis relapse	543.75	13.52	370	58674	46163	79639181
Post transplant lymphoproliferative disorder	524.59	13.52	226	58818	11238	79674106
Adenovirus infection	513.50	13.52	204	58840	8243	79677101
Lymphocyte percentage decreased	504.56	13.52	175	58869	4801	79680543
Lymphopenia	501.29	13.52	301	58743	30256	79655088
White blood cells urine positive	496.23	13.52	182	58862	5893	79679451

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AA34	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
FDA EPC	N0000175659	CD52-directed Cytolytic Antibody
FDA MoA	N0000175079	CD52-directed Antibody Interactions
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000074322	Antineoplastic Agents, Immunological

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Refractory chronic lymphocytic leukemia	indication	92814006
Conditioning treatment prior to allogeneic haematopoietic stem cell transplant	indication	234336002
Relapsing remitting multiple sclerosis	indication	426373005	DOID:2378
Recurrent chronic lymphocytic leukemia	indication	122961000119105

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
CAMPATH-1 antigen	Surface antigen	P31358	CD52_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
009168	NDDF
009169	NDDF
117055	RXNORM
129472003	SNOMEDCT_US
16025	MMSL
213286	MMSL
391632007	SNOMEDCT_US
3A189DH42V	UNII
4021265	VUID
4021265	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Campath	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0357	INJECTION	30 mg	INTRAVENOUS	BLA	28 sections
Campath	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0357	INJECTION	30 mg	INTRAVENOUS	BLA	28 sections
LEMTRADA	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0200	INJECTION, SOLUTION, CONCENTRATE	12 mg	INTRAVENOUS	BLA	29 sections
LEMTRADA	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0200	INJECTION, SOLUTION, CONCENTRATE	12 mg	INTRAVENOUS	BLA	29 sections
LEMTRADA	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0200	INJECTION, SOLUTION, CONCENTRATE	12 mg	INTRAVENOUS	BLA	29 sections
LEMTRADA	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0200	INJECTION, SOLUTION, CONCENTRATE	12 mg	INTRAVENOUS	BLA	29 sections

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